SIA - Internet-administered CBT for Adolescents With Low Self-esteem

The study will investigate a novel CBT based treatment approach for low self-esteem among adolescents.

Study Overview

• Status: Completed
• Conditions: Self Esteem
• Intervention / Treatment: Behavioral: Cognitive behavior therapy

• Study Type: Interventional
• Enrollment (Actual): 52
• Phase: Not Applicable

Contacts and Locations

Study Locations

• Sweden
  • Linköping, Sweden
    • Linköping University

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 15 years to 19 years (Child, Adult)
• Accepts Healthy Volunteers: No
• Genders Eligible for Study: All

Description

Inclusion Criteria:

• Low self-esteem, as indicated by rating of < 20 the Rosenberg Self-Esteem Scale.
• Age between 15 and 19 years old.
• Access to a computer, smartphone, or tablet with internet access.
• Write and speak Swedish.
• In case of use of psychotropical medication, a stable dose for the past three months prior to registration and no planned changes during the treatment.

Exclusion Criteria:

• Other ongoing psychological treatment that affects the treatment received in the study.
• No comorbid severe depressive symptoms and no suicidal plans.
• Ongoing alcohol use disorder, as indicated by Alcohol Use Disorders Identification Test (AUDIT).
• Severe psychiatric comorbidities (e.g. psychosis, anorexia nervosa) that requires specialist care within the regular psychiatric care.

Study Plan

How is the study designed?

Design Details

• Primary Purpose: Treatment
• Allocation: Randomized
• Interventional Model: Parallel Assignment
• Masking: None (Open Label)

Number of Arms

2

Arms and Interventions

Participant Group / Arm	Intervention / Treatment
Experimental: Cognitive Behavior Therapy; Therapist-Guided Internet based Cognitive Behavior Therapy	Behavioral: Cognitive behavior therapy; Internet-based CBT intervention based on CBT theory as well as self-determination therapy for low self-esteem among adolescents.
No Intervention: Wait-list control; Wait-list control participants will receive the same treatment at the end of the study period.

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
Change in Rosenberg Self-Esteem Scale	A 10-item measure of self-esteem. Sum scores range between 0-30. A higher score indicates a higher self-esteem.	Before treatment, after 3 weeks, after 7 weeks and follow-up at 12 months after treatment termination.

Secondary Outcome Measures

Outcome Measure	Measure Description	Time Frame
Change in Brunnsviken Brief Quality of Life Questionnaire	Measure of subjective quality of life. Sum scores can range between 0 and 96. Higher scores indicate a higher quality of life.	Before treatment, after 7 weeks and follow-up at 12 months after treatment termination.
Change in Robson Self-concept Questionnaire	A 30-item measure of self-esteem. Sum scores range between 0-210. A higher score indicates a higher self-esteem.	Before treatment, after 7 weeks and follow-up at 12 months after treatment termination.
Change in Self-Compassion Scale Short Format	A 12-item measure of self-compassion. Sum scores range between 1-5. A higher score indicates higher self-compassion.	Before treatment, after 7 weeks and follow-up at 12 months after treatment termination.
Change in Performance based self-esteem Scale	A 4-item measure of performance based self-esteem. Sum scores range between 4-20. A higher score indicates a higher performance based self-esteem.	Before treatment, after 7 weeks and follow-up at 12 months after treatment termination.
Change in Patient Health Questionnaire	A 9 item measure of depressive symptoms. Sum scores range from 0-27. A higher score indicates more depressive symptoms.	Before treatment, after 7 weeks and follow-up at 12 months after treatment termination.
Change in Generalised Anxiety Disorder 7-item scale	Seven item measure of generalized anxiety disorder. Sum score range from 0 to 21, with higher scores indicating more generalized anxiety. Cut-offs for interpretation: 0-5 minimal anxiety, 6-9 mild anxiety, 10-14 moderate anxiety, and 15-21 severe anxiety.	Before treatment, after 7 weeks and follow-up at 12 months after treatment termination.
Change in Alcohol Use Disorder Identification Test	A 10 item measure of alcohol use disorders. Sum scores range from 0-40. A higher score indicates higher alcohol use.	Before treatment, after 7 weeks and follow-up at 12 months after treatment termination.
Change in Rathus assertiveness schedule - 6	Six item measure of assertiveness. Sum score range from -18 to 18. A higher score indicates higher assertiveness.	Before treatment, after 7 weeks and follow-up at 12 months after treatment termination.

Collaborators and Investigators

• Sponsor: Linkoeping University
• Investigators: Principal Investigator: Gerhard Andersson, Linkoeping University

Study record dates

Study Major Dates

• Study Start (Actual): February 15, 2021
• Primary Completion (Actual): February 15, 2022
• Study Completion (Actual): February 15, 2022

Study Registration Dates

• First Submitted: January 28, 2021
• First Submitted That Met QC Criteria: February 2, 2021
• First Posted (Actual): February 3, 2021

Study Record Updates

• Last Update Posted (Actual): September 19, 2022
• Last Update Submitted That Met QC Criteria: September 16, 2022
• Last Verified: September 1, 2022

More Information

Terms related to this study

• Keywords: cognitive behavior therapy
• Other Study ID Numbers: SIA

Drug and device information, study documents

• Studies a U.S. FDA-regulated drug product: No
• Studies a U.S. FDA-regulated device product: No